Food, drugs, devices › Ossur H / F
Device recall: The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Ar
Ossur H / F (Reykjavik) initiated this device recall on 26 Feb 2015; FDA lists 1 product record under event 70693, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 20 Nov 2015. Initiation: voluntary: firm initiated. Ossur H / F has 8 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Ossur H / F, Reykjavik, Iceland.
Reason for recall
"The firm is recalling Rheo Knee bionic prosthetic due to it being discovered during an internal audit of the service line that devices were released for distribution without fully going through the assembly process."
Distribution
"Worldwide distribution: US distribution in TN and country of: Austria."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1322-2015 | The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelligence to continuously adapt to the users walking style and environment. The RHEO KNEE recognizes and responds immediately to changes in speed, load and terrain, restoring the users… | 4715 units (2 units affected) | Class II | Terminated | 1 Apr 2015 |
Context
Other enforcement events for Ossur H / F
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 20 Aug 2024 | Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101 | Device | Class II | 1 |
| 25 Mar 2024 | RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component | Device | Class II | 4 |
| 26 Dec 2023 | Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002 | Device | Class II | 1 |
| 12 May 2023 | Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REF: L-621000; Icelock 62 | Device | Class II | 1 |
| 14 Mar 2016 | Ossur Lil Angel Vest P2 Kodel. Pediatric sized vest is a support structure used with the halo system for traumatic or ch | Device | Class II | 6 |
| 24 Feb 2016 | Knee Shield (Patella Cup) Product Usage: Knee Shield patella cup is an accessory used with the knee braces to provide pr | Device | Class II | 14 |
| 4 Mar 2015 | LP Rotate Foot System prosthetic device for fitting lower extremity amputations. -Low profile foot module with adjustabl | Device | Class II | 1 |
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The firm is recalling Rheo Knee bionic prosthetic due to it being discovered during an internal audit of the service line that devices were released for distribution without fully going through the assembly process."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution: US distribution in TN and country of: Austria."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 20 Nov 2015. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.